MAG-VUE Trial Version 1.0
Research type
Research Study
Full title
Efficacy and Safety of the Scharioth Macular Lens in Advanced Macular Disease: The MAG-VUE Trial (acronym MAG-VUE Trial).A single centre prospective trial
IRAS ID
272990
Contact name
Giuliana Silvestri
Contact email
Sponsor organisation
BHSCT
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Rationale for the study
The focus of this project is to test a new intraocular magnifying lens to find out if this would improve vision and quality of life in patients with poor vision due to advanced macular disease. The device is placed inside the eye surgically either during cataract surgery or at a secondary procedure after previous cataract surgery. The Scharioth Macular Lens (SML) is a new device which uses a magnifying button in the centre of an implantable intraocular lens which produces x2 magnification of objects help close to the eye. Advantages of the SML are; the magnification is only for near and therefore does not cause difficulties with walking or balance; it is inserted through a very small (2.2 mm) corneal incision making surgery safer and recovery fast; and the cost is low.Who would be eligible?
Participants with either Age-Related Macular Degeneration or Inherited Retinal Disease, who have had cataract surgery in one or both eyes, whose corrected visual acuity in the study eye is between 6/24- 6/60. The study will have 2 ARMS both interventional. Participants in ARM 1 will, following contact lens simulation trial, be offered the SML surgical Implant. Participants in ARM 2 will be offered the SML contact lens simulator to assess the efficacy of a contact lens simulator in producing useful magnification for the duration of the study. All eligible participants will receive the opportunity for an intervention. There will be no control ARM.The study will take place at the Belfast Health & Social Care Trust in Northern Ireland and aims to enrol 25 participants. Participants will be screened and if eligible will be enrolled in the study. There will be 10 visits in the study in total including surgery. Each Patient will be in the study for approximately 18 months.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0308
Date of REC Opinion
3 Aug 2020
REC opinion
Favourable Opinion